Disc-retained tubes for radiologically inserted gastrostomy (RIG): not up to the job?

Area of Science:

• Gastroenterology
• Interventional Radiology
• Medical Device Evaluation

Background:

• Gastrostomy tubes are crucial for enteral feeding.
• Disc-retained gastrostomy tubes offer an alternative fixation method.
• Assessing novel device performance is essential for patient safety.

Purpose of the Study:

• To evaluate the insertion procedure and performance of the Monarch disc-retained gastrostomy tube.
• To record complications and accidental displacements.
• To determine the feasibility of primary off-licence placement.

Main Methods:

• Prospective audit of disc-retained 12 F Monarch gastrostomy tubes.
• Insertion by interventional radiologists under conscious sedation with EEG monitoring.
• Follow-up at 1 week, 1 month, and weekly telephone support.

Main Results:

• 33% of tubes (6/18) displaced, with 22% completely dislodged.
• 11% of displacements were occult into the peritoneum.
• 22% of patients (4/18) developed stoma site infections.

Conclusions:

• The Monarch disc-retained gastrostomy tube is unsuitable for primary placement with current protocols.
• High complication rates, including displacement and infection, were observed.
• Regulatory bodies and manufacturers have been notified due to safety concerns.